NCT04929834

Novel Skin Care for Immunotherapy- Related Dermatologic Toxicities

Evaluation of Novel Skin Care Products for the Management of Immunotherapy- Related Dermatologic Toxicities

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Jessa Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Notwithstanding the continuous progress in cancer treatment, patients with cancer still have to cope with quality of life (QoL) - impairing complications. Especially an extensive spectrum of dermatologic toxicities has been associated with cancer treatments. The number and type of cutaneous toxicities have evolved over the past 50 years, paralleling the development of new immunomodulatory agents. The immunotherapy-related skin toxicities can significantly impede the patient's emotional, physical, social, and financial well-being resulting in a poor QoL. In rare cases of severe cutaneous reactions, treatment modifications are needed, resulting in a diminished overall survival. Important organizations in the field of oncology and supportive care, such as the MASCC, the ASCO, and the ESMO, have developed guidelines for the management of cancer therapy- related cutaneous toxicities based on available scientific evidence. Still, for some interventions, the evidence of recommendation is moderate to insufficient. Therefore, it is essential to elucidate other new potential management strategies for dermatological complications of cancer treatment. Based on the previously mentioned supportive care guidelines for the ImmunoSkin project, two novel skin care products to tackle the cutaneous adverse events of immunotherapy have been developed. The ImmunoSkin project general aim is to evaluate the efficacy of two novel skincare products to manage immunotherapy-related cutaneous toxicities.

Detailed description

Primary objective Evaluate the efficacy of two novel skin care products for the management of immunotherapy-related cutaneous adverse events Secondary objective 1 Evaluate patient-relevant treatment benefit of two novel skin care products for immunotherapy-related cutaneous toxicities Secondary objective 2 Evaluate the influence of two novel skin care products for immunotherapy-related cutaneous toxicities on the patient's quality of life Secondary objective 3 Evaluate the safety of two novel skin care products for immunotherapy-related cutaneous toxicities

Conditions

• Skin Toxicity
• Immunotoxicity

Interventions

Type	Name	Description
OTHER	Hydrating emollient + body lotion for immunotherapy-related side effects	Hydrating, hypo-allergenic, and anti- itching emollient and body lotion for immunotherapy-related skin reactions

Timeline

• Start date: 2021-10-20
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-06-18
• Last updated: 2023-02-28

Locations

1 site across 1 country: Belgium